Description

Responsibilities

  • Develop, document, and execute verification test methods to evaluate performance metrics of complex, electromechanical medical systems.
  • Update test architecture with focus on Continuous Integration.
  • Setup and debug verification test apparatus and fixtures that include oscilloscopes, digital multimeters, force sensors, digital measurement systems, and other electronic measurement equipment.
  • Analyze multidimensional datasets using Python and Matlab scripts.
  • Write test reports following proper SOP and QA procedures.
  • Release components, test fixtures, and documents in Agile.
  • Develop and perform test method validations.
  • Specify and purchase measurement equipment and maintain calibration records.

Required Skills

  • Fundamental understanding of validated computer systems and change management in the commercial pharmaceutical/biotech industry, including training others.
  • Strong communication skills.
  • Good project management skills.
  • Self-starter, energetic, independent work ethic.
  • Self-starter who works with minimal supervision and the ability to work in a team of diverse skill sets.
  • To learn new skills and grow competencies.
  • Ability to work in a team-oriented, collaborative environment.

Required Experience

  • 1 to 3 years of experience in the medical device industry highly preferred.
  • At least 3 years of experience in the Pharmaceutical or Bio-Pharmaceutical Industries.
  • Experience executing Facilities, HVAC System, Laboratory Equipment protocols, IQ/OQ/PQ, Protocols, among others.

Education Requirements

  • Bachelor’s Degree in Computer Science, Computer Engineering or a closely related field.


 

Education

Any Graduate